OPDUALAG- nivolumab and relatlimab-rmbw injection 
E.R. Squibb & Sons, L.L.C.


Medication Guide


OPDUALAG™ (op-DEW-uh-lag)

(nivolumab and relatlimab-rmbw)


What is the most important information I should know about OPDUALAG?

OPDUALAG is a medicine that may treat a type of skin cancer called melanoma by working with your immune system. OPDUALAG can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. You may have more than one of these problems at the same time.

Call or see your healthcare provider right away if you develop any new or worse signs of symptoms, including:

Lung problems.

new or worsening cough
shortness of breath
chest pain

Intestinal problems.

diarrhea (loose stools) or more frequent bowel movements than usual
stool that are black, tarry, sticky, or have blood or mucus
severe stomach-area (abdominal) pain or tenderness

Liver problems.

yellowing of your skin or the whites of your eyes
severe nausea or vomiting
pain on the right side of your stomach area (abdomen)
dark urine (tea colored)
bleeding or bruising more easily than normal

Hormone gland problems.

headaches that will not go away or unusual headaches
eye sensitivity to light
eye problems
rapid heartbeat
increased sweating
extreme tiredness
weight gain or weight loss
feeling more hungry or thirsty than usual
urinating more often than usual
hair loss
feeling cold
your voice gets deeper
dizziness or fainting
changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems.

decrease in your amount of urine
blood in your urine
swelling in your ankles
loss of appetite

Skin problems.

skin blistering or peeling
painful sore or ulcers in mouth or nose, throat, or genital area

Heart problems.

new or worse chest pain
irregular heartbeat or feel like your heart is racing
shortness of breath
swelling in your ankles

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with OPDUALAG. Call or see your healthcare provider right away for any new or worsening sign or symptoms, which may include:

Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
Persistent or severe muscle pain or weakness, muscle cramps
Low red blood cells, bruising

Getting medical treatment right away may keep these problems from becoming more serious.

Your healthcare provider will check you for these problems during treatment with OPDUALAG. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with OPDUALAG, if you have severe side effects.


OPDUALAG is a prescription medicine used to treat:

adults and children 12 years of age or older with a type of skin cancer called melanoma that has spread or cannot be removed by surgery.

It is not known if OPDUALAG is safe and effective when used:

in children 12 years of age or older who weigh less than 88 pounds (40 kg), or
in children younger than 12 years of age.

Before you receive OPDUALAG, tell your healthcare provider if you:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
have received an organ transplant
have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
are pregnant or plan to become pregnant. OPDUALAG can harm your unborn baby.
Females who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start receiving OPDUALAG.
You should use an effective method of birth control during and for at least 5 months after the last dose of OPDUALAG. Talk to your healthcare provider about birth control methods that you can use during this time.
Tell your healthcare provider right away if you become pregnant during treatment with OPDUALAG.
are breastfeeding or plan to breastfeed. It is not known if OPDUALAG passes into your breast milk. Do not breastfeed during treatment with OPDUALAG and for 5 months after the last dose of OPDUALAG.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive OPDUALAG?

Your healthcare provider will give you OPDUALAG into your vein through an intravenous (IV) line over 30 minutes.
OPDUALAG is usually given every 4 weeks.
Your healthcare provider will decide how many treatments you need.
Your healthcare provider will do blood tests to check you for side effects.
If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

What are the possible side effects of OPDUALAG?

OPDUALAG can cause serious side effects, including:

See “What is the most important information I should know about OPDUALAG?”
Severe infusion reactions. Tell your healthcare provider or nurse right away if you get these symptoms during an infusion of OPDUALAG:
chills or shaking
itching or rash
shortness of breath
feel like passing out
back or neck pain
Complications of stem cell transplant that uses donor stem cells (allogeneic). These complications can be severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with OPDUALAG. Your healthcare provider will monitor you for signs of complications if you have an allogeneic stem cell transplant.

The most common side effects of OPDUALAG include:

muscle and bone pain
decreased red blood cell and white blood cell counts
increased liver function test results
decreased salt (sodium) in your blood

These are not all the possible side effects of OPDUALAG.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of OPDUALAG.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about OPDUALAG that is written for health professionals.

What are the ingredients in OPDUALAG?

Active ingredients: nivolumab and relatlimab

Inactive ingredients: histidine, L-histidine hydrochloride monohydrate, pentetic acid, polysorbate 80, sucrose, and Water for Injection.


OPDUALAG™ is trademark of Bristol-Myers Squibb Company. Other brands listed are the trademarks of their respective owners.

Manufactured by: Bristol-Myers Squibb Company Princeton, NJ 08543 USA U.S. License No. 1713

For more information, call 1-855-673-4861 or go to www.OPDUALAG.com.

This Medication Guide has been approved by the U.S. Food and Drug Administration.     Revised: March 2022

Revised: 3/2024
E.R. Squibb & Sons, L.L.C.